Xper Information Management System 98960612834x

GUDID 00884838098985

The information management system is intended for use under the direct supervision of a healthcare practitioner for acquiring, displaying, trending, storing and transmitting various types of data, such as physiologic, hemodynamic, clinical, medical image and other related data. The system is capable of processing / analyzing information, such as multi-channel ECG signals, and performing other data management functions, such as creating reports. Data may be acquired from and/or sent to other devices, such as physiological monitoring systems, information management systems, image acquisition/storage devices, and other medical devices. The system is indicated for use in the following areas: cardiology, cardiac catheterization, electrophysiology, radiology, invasive radiology, and surrounding areas where access to the information is needed. The system consists of modules and may be entirely a software offering or a hardware/software offering. It is intended for use on standard computer systems and does not require proprietary hardware. The solution is available as a single module or combination of modules, or may function as a standalone system. The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or internet, or may function as a standalone device.

Philips Medical Systems Nederland B.V.

Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system

• Primary Device ID: 00884838098985
• NIH Device Record Key: e2ca3a6f-1b0a-4bc1-8eb6-fa78441fda69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xper Information Management System
• Version Model Number: 2.6
• Catalog Number: 98960612834x
• Company DUNS: 413819707
• Company Name: Philips Medical Systems Nederland B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838098985 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101571

FDA Product Code

• DQK: Computer, diagnostic, programmable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-15
• Device Publish Date: 2020-01-07

On-Brand Devices [Xper Information Management System]

• 00884838087330: The Xper Information Management System is used for acquiring, displaying, trending, storing and
• 00884838085213: The information management system is intended for use under the direct supervision of a healthca
• 00884838081291: 2.2
• 00884838070721: 2.1
• 00884838070691: 1.5
• 00884838091771: The Xper Information Management System is used for acquiring, displaying, trending, storing and
• 00884838098985: The information management system is intended for use under the direct supervision of a healthca
• 00884838100084: The Xper Information Management System is used for acquiring, displaying, trending, storing and
• 00884838105034: The Information Management System is a software to acquire, display, trend, store, and transmit